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Chemistry

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Also known as: 162401-32-3, Daxas, 3-(cyclopropylmethoxy)-n-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide, Daliresp, By217, Byk20869
Molecular Formula
C17H14Cl2F2N2O3
Molecular Weight
403.2  g/mol
InChI Key
MNDBXUUTURYVHR-UHFFFAOYSA-N
FDA UNII
0P6C6ZOP5U

Roflumilast
Roflumilast is an orally available, long-acting inhibitor of phosphodiesterase (PDE) type 4 (PDE4), with anti-inflammatory and potential antineoplastic activities. Upon administration, roflumilast and its active metabolite roflumilast N-oxide selectively and competitively bind to and inhibit PDE4, which leads to an increase of both intracellular levels of cyclic-3',5'-adenosine monophosphate (cAMP) and cAMP-mediated signaling. cAMP prevents phosphorylation of spleen tyrosine kinase (SYK) and abrogates activation of the PI3K/AKT/mTOR signaling pathway, which may result in the induction of apoptosis. PDE4, a member of the PDE superfamily that hydrolyses cAMP and 3',5'-cyclic guanosine monophosphate (cGMP) to their inactive 5' monophosphates, is upregulated in a variety of cancers and may contribute to chemoresistance; it also plays a key role in inflammation, especially in inflammatory airway diseases.
Roflumilast is a Phosphodiesterase 4 Inhibitor. The mechanism of action of roflumilast is as a Phosphodiesterase 4 Inhibitor.
1 2D Structure

Roflumilast

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3-(cyclopropylmethoxy)-N-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide
2.1.2 InChI
InChI=1S/C17H14Cl2F2N2O3/c18-11-6-22-7-12(19)15(11)23-16(24)10-3-4-13(26-17(20)21)14(5-10)25-8-9-1-2-9/h3-7,9,17H,1-2,8H2,(H,22,23,24)
2.1.3 InChI Key
MNDBXUUTURYVHR-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1CC1COC2=C(C=CC(=C2)C(=O)NC3=C(C=NC=C3Cl)Cl)OC(F)F
2.2 Other Identifiers
2.2.1 UNII
0P6C6ZOP5U
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 3-cyclopropylmethoxy-4-difluoromethoxy-n-(3,5-di-chloropyrid-4-yl)benzamide

2. Daliresp

2.3.2 Depositor-Supplied Synonyms

1. 162401-32-3

2. Daxas

3. 3-(cyclopropylmethoxy)-n-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide

4. Daliresp

5. By217

6. Byk20869

7. By-217

8. B9302-107

9. By 217

10. 3-(cyclopropylmethoxy)-n-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)benzamide

11. Roflumilast (daxas)

12. Benzamide, 3-(cyclopropylmethoxy)-n-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)-

13. Byk-20869

14. 0p6c6zop5u

15. Chembl193240

16. Chebi:47657

17. 3-cyclopropylmethoxy-n-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide

18. Byk 20869

19. Mfcd00938270

20. B 9302-107

21. Rof

22. Libertek

23. Roflumilast [usan]

24. B-9302-107

25. Roflumilast [usan:inn]

26. Unii-0p6c6zop5u

27. Roflumilastum

28. Roflumilast (jan/usan/inn)

29. Apta-2217

30. 1xmu

31. 1xoq

32. Daliresp (tn)

33. Roflumilast- Bio-x

34. 3g4l

35. Roflumilast [mi]

36. Roflumilast [inn]

37. Roflumilast [jan]

38. 3-cyclopropylmethoxy-4-difluoromethoxy-n-(3,5-di-chloropyrid-4-yl)benzamide

39. Roflumilast [vandf]

40. Roflumilast [mart.]

41. Schembl19158

42. Roflumilast [who-dd]

43. Mls006010074

44. Roflumilast [ema Epar]

45. Gtpl6962

46. Dtxsid8044123

47. Apta 2217

48. Bdbm14774

49. Roflumilast, >=98% (hplc)

50. Amy4219

51. Ex-a059

52. Roflumilast [orange Book]

53. Hms3655p21

54. Hms3748c19

55. Hms3884f09

56. Zinc592419

57. Act02619

58. Bcp03736

59. S2131

60. Arq-151/zoryve (roflumilast Cream)

61. Akos005146309

62. Am84550

63. Ccg-268678

64. Cs-0963

65. Db01656

66. Pb29130

67. Ncgc00346566-01

68. Ncgc00346566-09

69. Ac-23383

70. As-14120

71. Br164364

72. Hy-15455

73. Smr002530074

74. Sy008710

75. Bcp0726000146

76. Ft-0660846

77. R0193

78. Sw220196-1

79. A24672

80. D05744

81. Ab01565852_02

82. 401r323

83. Q693482

84. J-510858

85. Brd-k03194791-001-02-2

86. 3- Cyclo-propylmethoxy-4-difluoromethoxy-n- [3, 5-di-chloropyrid-4-yl]- Benzamid

87. Benzamide, 3-(cyclopropylmethoxy)-n-(3,5-dichloro-4-pyridinyl)-4-(difluoromethoxy)-

88. N-(3,5-dichloropyridin-4-yl)-4-difluoromethoxy-3-cyclopropylmethoxybenzamide

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 403.2 g/mol
Molecular Formula C17H14Cl2F2N2O3
XLogP34.6
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count7
Exact Mass402.0349540 g/mol
Monoisotopic Mass402.0349540 g/mol
Topological Polar Surface Area60.4 Ų
Heavy Atom Count26
Formal Charge0
Complexity475
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameDaliresp
PubMed HealthRoflumilast (By mouth)
Drug ClassesRespiratory Agent
Drug LabelThe active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylm...
Active IngredientRoflumilast
Dosage FormTablet
RouteOral
Strength500mcg
Market StatusPrescription
CompanyForest Res Inst

2 of 2  
Drug NameDaliresp
PubMed HealthRoflumilast (By mouth)
Drug ClassesRespiratory Agent
Drug LabelThe active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylm...
Active IngredientRoflumilast
Dosage FormTablet
RouteOral
Strength500mcg
Market StatusPrescription
CompanyForest Res Inst

4.2 Drug Indication

Roflumilast is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. Roflumilast is not a bronchodilator and is not indicated for the relief of acute bronchospasm.


FDA Label


Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.


Libertek is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.


Daliresp is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add-on to bronchodilator treatment.


Chronic obstructive pulmonary disease


5 Pharmacology and Biochemistry
5.1 Pharmacology

Roflumilast (and its active metabolite, roflumilast N-oxide) increases cyclic adenosine-3, 5-monophosphate (cAMP) in lung cells by inhibiting PDE4. Increased cAMP activates PKA, which inactivates transcription factors involved in inflammation. Romflumilast also decreases the amount of sputum neutrophils and eosinophils in COPD patients.


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
ROFLUMILAST
5.2.2 FDA UNII
0P6C6ZOP5U
5.2.3 Pharmacological Classes
Phosphodiesterase 4 Inhibitors [MoA]; Phosphodiesterase 4 Inhibitor [EPC]
5.3 ATC Code

R03DX07


R03DX08


R03DX07


R03DX07

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


R - Respiratory system

R03 - Drugs for obstructive airway diseases

R03D - Other systemic drugs for obstructive airway diseases

R03DX - Other systemic drugs for obstructive airway diseases

R03DX07 - Roflumilast


5.4 Absorption, Distribution and Excretion

Absorption

After a 500mcg dose, the bioavailability of roflumilast is about 80%. In the fasted state, maximum plasma concentrations are reached in 0.5 to 2 hours. While in the fed state, Cmax is reduced by 40%, Tmax is increased by one hour, and total absorption is unchanged.


Route of Elimination

Roflumilast is excreted 70% in the urine as roflumilast N-oxide.


Volume of Distribution

Roflumilast has a Vd of 2.9L/kg with a dose of 500mcg. Permeability of roflumilast across the blood-brain barrier appears to be poor in rat studies.


Clearance

~9.6 L/hour.


5.5 Metabolism/Metabolites

Roflumilast is metabolized to roflumilast N-oxide, the active metabolite of roflumilast in humans, by CYP3A4 and CYP1A2.


5.6 Biological Half-Life

Plasma half-life of roflumilast is 17 hours and its metabolite is 30 hours (oral dose).


5.7 Mechanism of Action

Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE4 isoenzyme, has potential antiinflammatory and antimodulatory effects in the pulmonary system. It is thought that the increased levels of intracellular cyclic AMP are responsible for the therapeutic actions of Roflumilast.


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DMF Review : Complete

Rev. Date : 2015-01-05

Pay. Date : 2014-07-23

DMF Number : 28471

Submission : 2014-07-31

Status : Active

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Submission : 2014-03-28

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DMF Number : 28506

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Roflumilast IH

Date of Issue : 2025-08-08

Valid Till : 2028-06-10

Written Confirmation Number : WC-0017

Address of the Firm : Unit-II, SurveyNo.:10&13,Gaddapotharam (Village), IDA-Kazipally, Jinnaram (Manda...

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Date of Issue : 2025-09-19

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Address of the Firm : Unit-l, Sy. No. 213, 214 & 255, Bonthapally (Village),Gummadidala (Mandal), Sang...

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Date of Issue : 2025-07-07

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Address of the Firm : Sy. Nos, 317,320,321,322,323,604 & 605, Pincode-502329, Rudraram (Village), Pata...

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Roflumilast

Registrant Name : Seongi Bio Co., Ltd.

Registration Date : 2016-12-29

Registration Number : Su259-4-ND

Manufacturer Name : Interquim, SA

Manufacturer Address : Joan Buscalla 10, E-08173 Sant Cugat del Valles, Barcelona, ​​Spain

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Undifferentiated flumilast

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2021-07-20

Registration Number : Su258-14-ND

Manufacturer Name : MSN Laboratories PVT.LTD

Manufacturer Address : Sy. No. 317 , 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal),...

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Roflumilast

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2017-04-03

Registration Number : Su258-2-ND

Manufacturer Name : MSN Laboratories Private Lim...

Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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Polaris AI Pharma

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Roflumilast

Registrant Name : Polaris AI Pharma Co., Ltd.

Registration Date : 2024-11-29

Registration Number : 1962-9-ND

Manufacturer Name : Polaris AI Pharma Co., Ltd.

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Roflumilast

Registrant Name : AstraZeneca Korea Ltd.

Registration Date : 2011-04-29

Registration Number : Su5550-1-ND

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ROFLUMILAST

NDC Package Code : 64552-4067

Start Marketing Date : 2011-02-28

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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ROFLUMILAST

NDC Package Code : 64552-4053

Start Marketing Date : 2011-02-28

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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ROFLUMILAST

NDC Package Code : 64552-4096

Start Marketing Date : 2011-02-28

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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ROFLUMILAST

NDC Package Code : 59651-222

Start Marketing Date : 2023-12-07

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (50kg/50kg)

Marketing Category : BULK INGREDIENT

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ROFLUMILAST

NDC Package Code : 73377-310

Start Marketing Date : 2025-02-26

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1g/g)

Marketing Category : BULK INGREDIENT FOR HUMAN P...

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ROFLUMILAST

NDC Package Code : 65977-0111

Start Marketing Date : 2011-02-28

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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ROFLUMILAST

NDC Package Code : 14501-0078

Start Marketing Date : 2012-03-22

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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08

ASCO GU
Not Confirmed
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ASCO GU
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ROFLUMILAST

NDC Package Code : 65129-1319

Start Marketing Date : 2013-12-02

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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09

ASCO GU
Not Confirmed
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ASCO GU
Not Confirmed

ROFLUMILAST

NDC Package Code : 61730-0010

Start Marketing Date : 2023-12-06

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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10

ASCO GU
Not Confirmed
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ROFLUMILAST

NDC Package Code : 82245-0118

Start Marketing Date : 2018-01-23

End Marketing Date : 2027-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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01

Interquim SA

Spain
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothInterquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.

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Digital Content Digital Content

Roflumilast

About the Company : Interquim, founded in 1978 and part of Ferrer HealthTech, develops high-value APIs with strict quality standards. Its facilities comply with European regulations, and products are ...

Interquim, founded in 1978 and part of Ferrer HealthTech, develops high-value APIs with strict quality standards. Its facilities comply with European regulations, and products are exported to regulated markets. Approved by regulators and clients, Interquim supports clients from development to marketing with advanced production and quality-control labs. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Interquim

02

Inke S.A

Spain
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothInke S.A: APIs manufacturing plant.

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Digital Content Digital Content

Roflumilast

About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...

Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse therapeutic areas, but mainly for use in Respiratory. Inke has been successfully inspected by every major global authority for a wide array of products (last inspection on behalf of US-FDA was in 2023). For the last two decades, the company has made strong strides to become a prestige provider of respiratory APIs for inhalation. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Inke Company Banner

03

LGM Pharma

U.S.A
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Digital Content Digital Content

Roflumilast

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulation, analytical method development and testing, custom API synthesis, regulatory support, and commercial manufacturing. Supported by a network of over 300 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
LGM Pharma CB

04

HRV Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHRV Pharma - Market Expansion Leader in Pharmaceuticals.

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Digital Content Digital Content

Roflumilast

About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...

HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing, manufacturing, and supply services to support partners entering new markets worldwide. HRV Pharma works closely with major pharma and food additive companies and represents over 30 Indian drugmakers, primarily serving Europe, the US, and the Middle East. Headquartered in India, it operates offices in the US, Switzerland, Dubai, Lithuania, and Turkey. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
HRV Global Life Sciences

05

ASCO GU
Not Confirmed
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ASCO GU
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Roflumilast

About the Company : Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company comme...

Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born off a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry. Aurobindo Pharma became a public company in 1992 and listed its shares in the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillins, it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and cephalosporins, among others.
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06

ASCO GU
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ASCO GU
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Roflumilast

About the Company : Beijing Mesochem Technology Co. Ltd., located in the Yizhuang National Economic and Technological Development Area, China, manufactures pharmaceutical chemicals, fine chemicals, an...

Beijing Mesochem Technology Co. Ltd., located in the Yizhuang National Economic and Technological Development Area, China, manufactures pharmaceutical chemicals, fine chemicals, and basic chemical materials. The company has an experienced R&D team and provides customized development, process optimization, contract manufacturing, and outsourcing services. Beijing Mesochem operates a production base in Weinan, Shanxi Province, featuring a 20,000 ㎡ facility with an annual capacity exceeding 8,000 MT. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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07

CHEMO

Spain
ASCO GU
Not Confirmed
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CHEMO

Spain
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ASCO GU
Not Confirmed

Roflumilast

About the Company : More than 35 years of dedication to quality, service and pursuit of excellence, CHEMO was founded by Hugo Sigman, M.D., and Silvia Gold, Biochemist, in Spain (Barcelona), in 1977, ...

More than 35 years of dedication to quality, service and pursuit of excellence, CHEMO was founded by Hugo Sigman, M.D., and Silvia Gold, Biochemist, in Spain (Barcelona), in 1977, and starts business activities trading with pharmaceutical raw materials. In the 80's, the company expanded its operations into the Industrial Business, developing and manufacturing active pharmaceutical ingredients (APIs) in Italy (Industriale Chimica) and in Spain (Quimica Sintetica). In the 90's, CHEMO starts developing and manufacturing high quality and technology finished dosage forms (FDFs).
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08

DEAFARMA

Italy
ASCO GU
Not Confirmed
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DEAFARMA

Italy
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ASCO GU
Not Confirmed

Roflumilast

About the Company : In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territo...

In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territory. DEAFARMA works with success in the pharmaceutical raw materials field through Agencies and professional relations with the most important European and Asiatic factories. Our partners are well known, reliable producers and all of them are operating in accordance with the latest GMP Rules. The APIs mentioned in the DEAFARMA catalogue are always supported by DMF and/or CEP.
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09

M2i Group

France
ASCO GU
Not Confirmed
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M2i Group

France
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ASCO GU
Not Confirmed

Roflumilast

About the Company : Integrated solutions for all your projects.
M2i Group provides integrated solutions for all your projects. We offer our clients an integrated partner, from early development...

Integrated solutions for all your projects. M2i Group provides integrated solutions for all your projects. We offer our clients an integrated partner, from early development to commercial supply of high-value niche fine chemicals for the pharmaceutical and biocontrol industry. Our offerings include: - Proprietary molecule portfolio: API, synthesis intermediates, key building blocks & pheromones - Custom development & manufacturing: Process development, industrialization & production - Contract Research: Outsourced research services - Consulting/accompaniment: R&D, innovation, key sourcing & industrial strategy
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10

ASCO GU
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Roflumilast

About the Company : Founded in 2007, Melody Healthcare is a rapidly growing, quality-oriented leading manufacturer of APIs, with a distinct emphasis on the development and production of technology-dri...

Founded in 2007, Melody Healthcare is a rapidly growing, quality-oriented leading manufacturer of APIs, with a distinct emphasis on the development and production of technology-driven products. Located in India, within a Government Approved industrial zone (MIDC) in Tarapur, Maharashtra, Melody Healthcare features advanced manufacturing facilities that comply with global regulatory standards and concentrate on specialized therapeutic areas, providing products in these segments: Respiratory, Hypertensive, Cardiovascular, Antibiotic
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API Reference Price

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C-24,INDUSTRIAL HYDERABAD","city":"HYDERABAD","supplier":"MSN LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"SHANGHAI","customer":"UNDISCLOSED","customerCountry":"CHINA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"225000","totalValueFC":"110401.4","currency":"USD","unitRateINR":17226000,"date":"15-Jun-2022","totalValueINR":"8613000","totalValueInUsd":"110401.4","indian_port":"HYDERABAD AIR","hs_no":"29339990","bill_no":"2132849","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE, PLOT NO. 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S_22_0429382, PRPN.","address":"TORRENT HOUSE, OFF ASHRAM ROAD,","city":"AHMEDABAD","supplier":"TORRENT PHARMACEUTICALS LTD","supplierCountry":"INDIA","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"JASPER HOLZERDEPUTY HEAD OF QC","customerCountry":"GERMANY","quantity":"0.00","actualQuantity":"4","unit":"GMS","unitRateFc":"122.1","totalValueFC":"513.7","currency":"EURO","unitRateINR":10500,"date":"21-Jan-2023","totalValueINR":"42000","totalValueInUsd":"513.7","indian_port":"DELHI AIR","hs_no":"29339990","bill_no":"7145054","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"DELHI AIR","supplierAddress":"TORRENT HOUSE, OFF ASHRAM ROAD,, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677177000,"product":"ROFLUMILAST STANDARD FOR TESTING PURPOSE","address":"TORRENT HOUSE, OFF ASHRAM ROAD,","city":"AHMEDABAD","supplier":"TORRENT PHARMACEUTICALS LTD","supplierCountry":"INDIA","foreign_port":"LONDON - HEATHROW","customer":"ACE LABORATORIES LTD","customerCountry":"UNITED KINGDOM","quantity":"0.00","actualQuantity":"1.5","unit":"GMS","unitRateFc":"105.6","totalValueFC":"193.7","currency":"GBP","unitRateINR":10666.666666666666,"date":"24-Feb-2023","totalValueINR":"16000","totalValueInUsd":"193.7","indian_port":"DELHI AIR","hs_no":"29339990","bill_no":"8040697","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"DELHI AIR","supplierAddress":"TORRENT HOUSE, OFF ASHRAM ROAD,, AHMEDABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688927400,"product":"ROFLUMILAST IH-PHARMACEUTICAL RAW MATERI","address":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con","city":"HYDERABAD","supplier":"HETERO DRUGS LTD","supplierCountry":"INDIA","foreign_port":"PHILADELPHIA METROP","customer":"UNDISCLOSED","customerCountry":"UNITED STATES","quantity":"0.95","actualQuantity":"0.952","unit":"KGS","unitRateFc":"42700","totalValueFC":"40248.4","currency":"USD","unitRateINR":3474789.8823529412,"date":"10-Jul-2023","totalValueINR":"3307999.968","totalValueInUsd":"40248.4","indian_port":"HYDERABAD AIR","hs_no":"29333911","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"7-2-A2, HETERO CORPORATE, INDUSTRIAL ESTATE, SANATHNAGAR, Con, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1692210600,"product":"CS-O-11739 \/ ROFLUMILAST","address":"17 LOTUS BUSINESS PARKNEW LINK RD ANDHERI W","city":"MUMBAI","supplier":"CLEARSYNTH LABS LTD","supplierCountry":"INDIA","foreign_port":"HO CHI MINH CITY","customer":"ONLAB SCIENTIFIC CO LTD","customerCountry":"VIETNAM","quantity":"0.00","actualQuantity":"1","unit":"GMS","unitRateFc":"240","totalValueFC":"236.6","currency":"USD","unitRateINR":19600.308000000001,"date":"17-Aug-2023","totalValueINR":"19600.308","totalValueInUsd":"236.6","indian_port":"BOMBAY AIR","hs_no":"29339990","bill_no":"0","productDescription":"API","marketType":"","country":"VIETNAM","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"17 LOTUS BUSINESS PARKNEW LINK RD ANDHERI W, MUMBAI","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699813800,"product":"ROFLUMILAST USP","address":"MSN HOUSE, PLOT NO. 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C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"PHARMAPIA CO LTD","customerCountry":"KOREA, REPUBLIC OF","quantity":"0.30","actualQuantity":"0.3","unit":"KGS","unitRateFc":"180000","totalValueFC":"53343.7","currency":"USD","unitRateINR":14863526.666666668,"date":"11-Jul-2024","totalValueINR":"4459058","totalValueInUsd":"53343.7","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2344233","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720722600,"product":"ROFLUMILAST USP","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"SHANGHAI - PU DONG","customer":"ZHEJIANG HUAHAI PHARMA CO LTD","customerCountry":"CHINA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"215000","totalValueFC":"212588.9","currency":"USD","unitRateINR":17770534.289999999,"date":"12-Jul-2024","totalValueINR":"17770534.29","totalValueInUsd":"212588.9","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2379334","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729189800,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER : F32512200781 DT.16.10.2024 ROFLUMILAST","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"GLENMARK LIFE SCIENCES LTD","supplierCountry":"INDIA","foreign_port":"MIAMI","customer":"TO THE ORDER URUGUAYURUGAY","customerCountry":"UNITED STATES","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"90000","totalValueFC":"8713.4","currency":"USD","unitRateINR":7321600,"date":"18-Oct-2024","totalValueINR":"732160","totalValueInUsd":"8713.4","indian_port":"Dahez-SEZ","hs_no":"29331999","bill_no":"4909851","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Dahez-SEZ","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1736274600,"product":"ROFLUMILAST USP","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"TARO PHARMACEUTICALS INC","customerCountry":"CANADA","quantity":"1.50","actualQuantity":"1.5","unit":"KGS","unitRateFc":"100000","totalValueFC":"147548.4","currency":"USD","unitRateINR":8481986.2000000011,"date":"08-Jan-2025","totalValueINR":"12722979.3","totalValueInUsd":"147548.4","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"7110425","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747161000,"product":"ROFLUMILAST USP","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"NEWARK, NJ","customer":"CORE PHARMA LLC","customerCountry":"UNITED STATES","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"100000","totalValueFC":"19519.6","currency":"USD","unitRateINR":8315430,"date":"14-May-2025","totalValueINR":"1663086","totalValueInUsd":"19519.6","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"1775987","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748457000,"product":"ROFLUMILAST","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"NEWARK, NJ","customer":"CORE PHARMA LLC","customerCountry":"UNITED STATES","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"100000","totalValueFC":"9827.8","currency":"USD","unitRateINR":8373360.4000000004,"date":"29-May-2025","totalValueINR":"837336.04","totalValueInUsd":"9827.8","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"2258086","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1749148200,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER : F32612200317DT. 31.05.2025 ROFLUMILAST","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"ALIVUS LIFE SCIENCES LTD","supplierCountry":"INDIA","foreign_port":"MIAMI","customer":"UNDISCLOSED","customerCountry":"UNITED STATES","quantity":"0.55","actualQuantity":"0.55","unit":"KGS","unitRateFc":"85000","totalValueFC":"46154.9","currency":"USD","unitRateINR":7210693.6363636358,"date":"06-Jun-2025","totalValueINR":"3965881.5","totalValueInUsd":"46154.9","indian_port":"Dahez-SEZ","hs_no":"29331999","bill_no":"2486386","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Dahez-SEZ","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1750962600,"product":"ROFLUMILAST USP","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"AMMAN","customer":"THE UNITED PHARMACEUTICALS MFGCOL","customerCountry":"JORDAN","quantity":"0.08","actualQuantity":"0.08","unit":"KGS","unitRateFc":"100000","totalValueFC":"7872.5","currency":"USD","unitRateINR":8455612.5,"date":"27-Jun-2025","totalValueINR":"676449","totalValueInUsd":"7872.5","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"3071277","productDescription":"API","marketType":"","country":"JORDAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1756751400,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS (API)EXPORT INVOICE NUMBER : F32612200705 DT.31.08.2025 ROFLUMILAST","address":"PLOT 170-172, CHANDRAMOULI,INDUSTR","city":"SOLAPUR,MAHARASHTRA","supplier":"ALIVUS LIFE SCIENCES LTD","supplierCountry":"INDIA","foreign_port":"MIAMI","customer":"UNDISCLOSED","customerCountry":"UNITED STATES","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"85000","totalValueFC":"8221.7","currency":"USD","unitRateINR":7257178,"date":"02-Sep-2025","totalValueINR":"725717.8","totalValueInUsd":"8221.7","indian_port":"Dahez-SEZ","hs_no":"29331999","bill_no":"4947098","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Dahez-SEZ","supplierAddress":"PLOT 170-172, CHANDRAMOULI,INDUSTR, SOLAPUR,MAHARASHTRA","customerAddress":""}]
26-Mar-2022
02-Sep-2025
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Drugs in Development

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Details:

Senores acquire the USFDA-approved abbreviated new drug application for Roflumilast, indicated as a treatment to reduce the risk of COPD exacerbations, from Breckenridge.


Lead Product(s): Roflumilast,Inapplicable

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Roflumilast-Generic

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Senores Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition February 21, 2025

Breckenridge Pharmaceutical

01

Details : Senores acquire the USFDA-approved abbreviated new drug application for Roflumilast, indicated as a treatment to reduce the risk of COPD exacerbations, from Breckenridge.

Product Name : Roflumilast-Generic

Product Type : Miscellaneous

Upfront Cash : Undisclosed

February 21, 2025

Breckenridge Pharmaceutical

Details:

In the termination of the deal involving Roflumilast, the focus on targeting Phosphodiesterase 4 for plaque psoriasis remains undisclosed.


Lead Product(s): Roflumilast,Inapplicable

Therapeutic Area: Dermatology Brand Name: Zoryve

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Kowa Pharmaceuticals America

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Termination January 26, 2026

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02

ASCO GU
Not Confirmed
ASCO GU
Not Confirmed

Details : In the termination of the deal involving Roflumilast, the focus on targeting Phosphodiesterase 4 for plaque psoriasis remains undisclosed.

Product Name : Zoryve

Product Type : Miscellaneous

Upfront Cash : Undisclosed

January 26, 2026

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Details:

ARQ-154 (Roflumilast) is a small molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of psoriasis.


Lead Product(s): Roflumilast,Inapplicable

Therapeutic Area: Dermatology Brand Name: ARQ-154

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 14, 2026

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03

ASCO GU
Not Confirmed
ASCO GU
Not Confirmed

Details : ARQ-154 (Roflumilast) is a small molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of psoriasis.

Product Name : ARQ-154

Product Type : Miscellaneous

Upfront Cash : Inapplicable

January 14, 2026

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Details:

Roflumilast is a small molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Hidradenitis Suppurativa.


Lead Product(s): Roflumilast,Inapplicable

Therapeutic Area: Dermatology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 04, 2025

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04

ASCO GU
Not Confirmed
ASCO GU
Not Confirmed

Details : Roflumilast is a small molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Hidradenitis Suppurativa.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 04, 2025

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Details:

Roflumilast, a phosphodiesterase 4 inhibitor, shows promise in treating atopic dermatitis.


Lead Product(s): Roflumilast,Inapplicable

Therapeutic Area: Dermatology Brand Name: Zoryve

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 30, 2025

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05

ASCO GU
Not Confirmed
ASCO GU
Not Confirmed

Details : Roflumilast, a phosphodiesterase 4 inhibitor, shows promise in treating atopic dermatitis.

Product Name : Zoryve

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 30, 2025

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  • Development Update

Details:

Roflumilast is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Vitiligo.


Lead Product(s): Roflumilast,Inapplicable

Therapeutic Area: Dermatology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Arcutis Biotherapeutics

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 05, 2025

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06

Derm Texas

Country
arrow
ASCO GU
Not Confirmed

Derm Texas

Country
arrow
ASCO GU
Not Confirmed

Details : Roflumilast is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Vitiligo.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

August 05, 2025

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  • Development Update

Details:

Roflumilast is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Hidradenitis Suppurativa.


Lead Product(s): Roflumilast,Inapplicable

Therapeutic Area: Dermatology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Arcutis Biotherapeutics

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 22, 2025

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07

Tulane University

Country
arrow
ASCO GU
Not Confirmed

Tulane University

Country
arrow
ASCO GU
Not Confirmed

Details : Roflumilast is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Hidradenitis Suppurativa.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 22, 2025

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Details:

Zoryve (roflumilast) is a PDE4 inhibitor steroid-free foam which is indicated for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older.


Lead Product(s): Roflumilast,Inapplicable

Therapeutic Area: Dermatology Brand Name: Zoryve

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 22, 2025

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08

ASCO GU
Not Confirmed
ASCO GU
Not Confirmed

Details : Zoryve (roflumilast) is a PDE4 inhibitor steroid-free foam which is indicated for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older.

Product Name : Zoryve

Product Type : Miscellaneous

Upfront Cash : Inapplicable

May 22, 2025

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Details:

Zoryve (roflumilast) is a once-daily, PDE4 inhibitor steroid-free cream which is being investigated in 2-5 years of age patients with atopic dermatitis.


Lead Product(s): Roflumilast,Inapplicable

Therapeutic Area: Dermatology Brand Name: Zoryve

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 26, 2025

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09

ASCO GU
Not Confirmed
ASCO GU
Not Confirmed

Details : Zoryve (roflumilast) is a once-daily, PDE4 inhibitor steroid-free cream which is being investigated in 2-5 years of age patients with atopic dermatitis.

Product Name : Zoryve

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 26, 2025

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Details:

Roflumilast is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Psoriasis.


Lead Product(s): Roflumilast,Inapplicable

Therapeutic Area: Dermatology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 18, 2024

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10

ASCO GU
Not Confirmed
ASCO GU
Not Confirmed

Details : Roflumilast is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Psoriasis.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 18, 2024

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INTERMEDIATE SUPPLIERS

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01

Minakem

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

CAS Number : 5911-08-0

End Use API : Roflumilast

About The Company : MINAKEM is a cGMP custom manufacturer specializing in small molecule APIs, HPAPIs, and steroids. Its highly skilled R&D teams, supported by strong analytical an...

Minakem Comapny Banner

02

Minakem

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMinakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

CAS Number : 7051-34-5

End Use API : Roflumilast

About The Company : MINAKEM is a cGMP custom manufacturer specializing in small molecule APIs, HPAPIs, and steroids. Its highly skilled R&D teams, supported by strong analytical an...

Minakem Comapny Banner

03

ASCO GU
Not Confirmed
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ASCO GU
Not Confirmed
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CAS Number : 2516-33-8

End Use API : Roflumilast

About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

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04

LinkChem

China
ASCO GU
Not Confirmed
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LinkChem

China
ASCO GU
Not Confirmed
arrow

CAS Number : 1159429-52-3

End Use API : Roflumilast

About The Company : LinkChem is a leading China headquartered CMO | CRO provider within the pharmaceutical industry. Our core focus includes: custom synthesis, process development,...

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05

M2i Group

France
ASCO GU
Not Confirmed
arrow

M2i Group

France
ASCO GU
Not Confirmed
arrow

CAS Number : 7051-34-5

End Use API : Roflumilast

About The Company : Integrated solutions for all your projects.
M2i Group provides integrated solutions for all your projects. We offer our clients an integrated partner, fr...

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06

ASCO GU
Not Confirmed
arrow
ASCO GU
Not Confirmed
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CAS Number : 516-12-1

End Use API : Roflumilast

About The Company : We are a top producer of Pharmaceutical Intermediates, Specialty Chemicals, and More, with origins dating back to 1998. Globally renowned for its Organic Compou...

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07

ASCO GU
Not Confirmed
arrow
ASCO GU
Not Confirmed
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CAS Number : 139-85-5

End Use API : Roflumilast

About The Company : V & V Pharma Industries is a Manufacturer & Exporter of Active Pharmaceutical Ingredients (API's), Pharmaceutical Intermediates & Specialty Chemicals. V & V Pha...

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 250MCG

USFDA APPLICATION NUMBER - 22522

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DOSAGE - TABLET;ORAL - 500MCG

USFDA APPLICATION NUMBER - 22522

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02

SPI Pharma

U.S.A
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Parenteral

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Controlled & Modified Release

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APIs

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Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

ABOUT THIS PAGE

Looking for 162401-32-3 / Roflumilast API manufacturers, exporters & distributors?

Roflumilast manufacturers, exporters & distributors 1

78

PharmaCompass offers a list of Roflumilast API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Roflumilast manufacturer or Roflumilast supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Roflumilast manufacturer or Roflumilast supplier.

PharmaCompass also assists you with knowing the Roflumilast API Price utilized in the formulation of products. Roflumilast API Price is not always fixed or binding as the Roflumilast Price is obtained through a variety of data sources. The Roflumilast Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Roflumilast

Synonyms

162401-32-3, Daxas, 3-(cyclopropylmethoxy)-n-(3,5-dichloropyridin-4-yl)-4-(difluoromethoxy)benzamide, Daliresp, By217, Byk20869

Cas Number

162401-32-3

Unique Ingredient Identifier (UNII)

0P6C6ZOP5U

About Roflumilast

Roflumilast is an orally available, long-acting inhibitor of phosphodiesterase (PDE) type 4 (PDE4), with anti-inflammatory and potential antineoplastic activities. Upon administration, roflumilast and its active metabolite roflumilast N-oxide selectively and competitively bind to and inhibit PDE4, which leads to an increase of both intracellular levels of cyclic-3',5'-adenosine monophosphate (cAMP) and cAMP-mediated signaling. cAMP prevents phosphorylation of spleen tyrosine kinase (SYK) and abrogates activation of the PI3K/AKT/mTOR signaling pathway, which may result in the induction of apoptosis. PDE4, a member of the PDE superfamily that hydrolyses cAMP and 3',5'-cyclic guanosine monophosphate (cGMP) to their inactive 5' monophosphates, is upregulated in a variety of cancers and may contribute to chemoresistance; it also plays a key role in inflammation, especially in inflammatory airway diseases.

Roflumilast, Daxas Manufacturers

A Roflumilast, Daxas manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Roflumilast, Daxas, including repackagers and relabelers. The FDA regulates Roflumilast, Daxas manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Roflumilast, Daxas API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Roflumilast, Daxas manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Roflumilast, Daxas Suppliers

A Roflumilast, Daxas supplier is an individual or a company that provides Roflumilast, Daxas active pharmaceutical ingredient (API) or Roflumilast, Daxas finished formulations upon request. The Roflumilast, Daxas suppliers may include Roflumilast, Daxas API manufacturers, exporters, distributors and traders.

click here to find a list of Roflumilast, Daxas suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Roflumilast, Daxas USDMF

A Roflumilast, Daxas DMF (Drug Master File) is a document detailing the whole manufacturing process of Roflumilast, Daxas active pharmaceutical ingredient (API) in detail. Different forms of Roflumilast, Daxas DMFs exist exist since differing nations have different regulations, such as Roflumilast, Daxas USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Roflumilast, Daxas DMF submitted to regulatory agencies in the US is known as a USDMF. Roflumilast, Daxas USDMF includes data on Roflumilast, Daxas's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Roflumilast, Daxas USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Roflumilast, Daxas suppliers with USDMF on PharmaCompass.

Roflumilast, Daxas KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Roflumilast, Daxas Drug Master File in Korea (Roflumilast, Daxas KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Roflumilast, Daxas. The MFDS reviews the Roflumilast, Daxas KDMF as part of the drug registration process and uses the information provided in the Roflumilast, Daxas KDMF to evaluate the safety and efficacy of the drug.

After submitting a Roflumilast, Daxas KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Roflumilast, Daxas API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Roflumilast, Daxas suppliers with KDMF on PharmaCompass.

Roflumilast, Daxas WC

A Roflumilast, Daxas written confirmation (Roflumilast, Daxas WC) is an official document issued by a regulatory agency to a Roflumilast, Daxas manufacturer, verifying that the manufacturing facility of a Roflumilast, Daxas active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Roflumilast, Daxas APIs or Roflumilast, Daxas finished pharmaceutical products to another nation, regulatory agencies frequently require a Roflumilast, Daxas WC (written confirmation) as part of the regulatory process.

click here to find a list of Roflumilast, Daxas suppliers with Written Confirmation (WC) on PharmaCompass.

Roflumilast, Daxas NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Roflumilast, Daxas as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Roflumilast, Daxas API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Roflumilast, Daxas as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Roflumilast, Daxas and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Roflumilast, Daxas NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Roflumilast, Daxas suppliers with NDC on PharmaCompass.

Roflumilast, Daxas GMP

Roflumilast, Daxas Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Roflumilast, Daxas GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Roflumilast, Daxas GMP manufacturer or Roflumilast, Daxas GMP API supplier for your needs.

Roflumilast, Daxas CoA

A Roflumilast, Daxas CoA (Certificate of Analysis) is a formal document that attests to Roflumilast, Daxas's compliance with Roflumilast, Daxas specifications and serves as a tool for batch-level quality control.

Roflumilast, Daxas CoA mostly includes findings from lab analyses of a specific batch. For each Roflumilast, Daxas CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Roflumilast, Daxas may be tested according to a variety of international standards, such as European Pharmacopoeia (Roflumilast, Daxas EP), Roflumilast, Daxas JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Roflumilast, Daxas USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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